Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Ammonium Lactate Cream, 12% is available as follows: 385 g bottle (NDC 63629-8609-1) STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].; Ammonium Lactate 12% Cream, #385 Label
- HOW SUPPLIED Ammonium Lactate Cream, 12% is available as follows: 385 g bottle (NDC 63629-8609-1) STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
- Ammonium Lactate 12% Cream, #385 Label
Overview
*Ammonium Lactate Cream, 12% is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4 - 5.4. Ammonium Lactate Cream, 12% also contains cetyl alcohol, glycerin, glyceryl stearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, and purified water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula: Ammonium Lactate Cream Structural Formula
Indications & Usage
Ammonium Lactate Cream, 12% is indicated for the treatment of ichthyosis vulgaris and xerosis.
Dosage & Administration
Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.
Warnings & Precautions
WARNING Sun exposure to areas of the skin treated with Ammonium Lactate Cream, 12% should be minimized or avoided (see PRECAUTIONS ). Use of this product should be discontinued if hypersensitivity to any of the ingredients is noted.
Contraindications
Ammonium Lactate Cream, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.
Adverse Reactions
In controlled clinical trials of patients with ichthyosis vulgaris, the most frequent adverse reactions in patients treated with ammonium lactate cream were rash (including erythema and irritation) and burning/stinging. Each was reported in approximately 10-15% of patients. In addition, itching was reported in approximately 5% of patients. In controlled clinical trials of patients with xerosis, the most frequent adverse reactions in patients treated with ammonium lactate cream were transient burning, in about 3% of patients, stinging, dry skin and rash, each reported in approximately 2% of patients.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.